PF-06881893 (Nivestym ™), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen ® ): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers

ConclusionsNivestym demonstrated PK and PD equivalence in single and multiple subcutaneous-dose settings and non-inferiority for immunogenicity to US-Neupogen, with a comparable safety profile, supporting the demonstration of biosimilarity.Trial registrationClinicalTrials.gov C1121002 (NCT02766647); C1121003 (NCT02766634); C1121012 (NCT02923791).
Source: BioDrugs - Category: Drugs & Pharmacology Source Type: research